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Clinical Research Associate - RTI International

Location: Durham, NC
Full-time position
Closing Date: June 18, 2017
Job #11462
Posted: May 18, 2017
Description:
Do you have a passion for research that could influence public health or solve complex problems?  Have you ever wanted to help solve problems facing our country?  If so, we have the opportunity for you! Come join our team to deliver the promise of science for the global good.
 
RTI International’s technical and scientific staff conduct health research and provide technical services to improve health in the U.S. and around the globe. We are seeking experienced candidates to support our work to improve the human condition for military populations.  
 
RTI is seeking a Clinical Research Associate (CRA) to provide support for conducting studies in accordance with federal and hospital regulations.  The CRA may also have responsibility for budget negotiation, monthly invoicing, account management, and regulatory paperwork and assist the client with outreach, identifying additional funding opportunities to support research, proposal and protocol preparation and submission.  This position is based within Madigan Army Medical Center (located in Washington state) and through the Regional Health Command – Pacific. 
 
Responsibilities:
• Administer and conduct the daily operation of the clinical investigation including scheduling
• Supply and equipment needs, maintenance and oversight; study personnel oversight; and subject recruitment strategy and execution. 
• Assist the Principal Investigator in answering the research questions by executing the routine functions of the research study/studies and administrative oversight of the project(s) to ensure that it is executed successfully. 
• Provide coordination of investigators with study site personnel.
• Create Standard Operating Procedures (SOPs) for and maintain oversight and responsibility for all study data collection processes as outlined in IRB approved protocols, including archiving and file management
• Complete initial set up and close-out of study/studies files and databases, collection and data entry, and on- going organization and maintenance of all research study/studies records and data in a computerized format.
• Assist the principle investigators with assorted administrative tasks as needed. Some flexibility may be needed to respond quickly to unanticipated mission requirements and accurately collect and file data.
• Responsible for all study approval submissions and processes.
• Adhere to legal, professional and ethical codes with respect to confidentiality and privacy.
• Responsible for explaining research protocols and obtaining signed consent from patients and research trial candidates as required per protocol.
• Assist investigators as needed with construction and maintenance of study databases and study data collection forms, and data entry tasks. Build data files and manage data entry of all data, maintaining an updated and organized literature library, on-going communication with the research team(s) to maximize study objectives as well as the collection of data at required study points per study protocol(s). 
• Provide regulatory compliance support to include preparation of IRB amendments, annual report, etc. and assist with preparing sponsor technical reports and/or site Command reports. They will also be responsible for maintaining study files in accordance with the standards of Good Conduct of Research
• Ensure compliance with subject consenting and reporting of adverse events and side effects.
• Track the expenditures for all study-related activities, including supplies and equipment. 
• Provide inputs to final reports that document the research findings for human use protocols including, but not limited to those listed above.
• Assist with the development of new studies, to include assist with writing, packaging, and submitting of research study proposals. Assist with identifying new funding sources and collaborators. 
• Assist the Strategic Outreach Service in meeting coordination between Madigan research investigators and extramural collaborators interested in performing quality improvement/quality assurance (QI/QA) and clinical research. Coordination includes, but is not limited to, emailing involved parties, agenda creation, escorting of visiting parties, and follow-up coordination. 
• Notifying Madigan research investigators of relevant funding opportunities, with an emphasis on the acquisition of DoD intramural funds. 
• Assist Madigan research investigators and its collaborators, as directed by DCI leadership, in the preparation of research proposals and protocols involving human subject clinical research coordination. 
• Perform other duties as assigned.
 

Qualifications:

• Bachelor’s degree and a minimum of 3 years of experience working in clinical trials or clinical research environment, with knowledge of medical terminology.

• Experience in clinical research processes: reviewing case reports, coordinating the flow of information between case workers, IRB, medical monitor and principal investigator, handling case report forms in a secure manner and be certified under the HIPPA regulations regarding patient information
• Knowledge of HIPAA, ICH, GCP and FDA regulations and processes, IRB applications and review processes, financial disclosure regulations, protocol design and development, clinical trial management and monitoring, and Adverse Event protocol.
• Knowledge of research data collection and records maintenance.
• Good oral and written communication skills, computer skills and experience with various data collection software. 
• Knowledge of record keeping practices specific to clinical research and human subject confidentiality. 
• Proficiency with Microsoft office suite including Word, Excel and PowerPoint.
• Must be willing to learn the data collection requirements and techniques per protocol
• Knowledge of CHCS and AHLTA a plus.
• To qualify, applicants must be legally authorized to work in the United State and should not require now, or in the future, sponsorship for employment visa status.

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